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Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit (MALICUS)

Primary Purpose

Malnutrition, Critical Illness

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malnutrition focused on measuring malnutrition, muscle ultrasound, intensive care unit, mechanical ventilation, albumin, prealbumin, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Study Population

Subjects will be enrolled from 2 venues:

  1. Adults ICU patients (> 18 years) requiring period of mechanical ventilation. Subjects affiliated with an appropriate social security system
  2. Adults patients admit requiring ICU length of stay < 48h after eligible surgery
  1. MALICUS Study

    Inclusion Criteria:

    - Patient requiring invasive mechanical ventilation

    - Expected duration of ventilation longer than 48 hours

    - Age > 18 years

    • Subjects affiliated with an appropriate social security system

    Non inclusion Criteria:

    - Invasive mechanical ventilation started for more than 48 hours

    - Patient severely malnourished at baseline (at least one of the following criteria)

    • Prealbuminemia < 0,11 g/L
    • BMI ≤ 18,5 (or ≤ 22 beyond 70 years)
    • Unintentional weight loss > 5% in the previous month or > 10% in the last 6 months - Glomerular nephropathy history/nephrotic syndrome, chronic renal failure (MDRD < 30 ml/min), liver cirrhosis or exudative gastro-enteropathy - Glucocorticoid (> 10 mg / day of prednisone equivalent ) long-term therapy ( > 1 month) - Impossible ultrasound measure of anterolateral diameter for the two quadriceps muscles

      - Neuromuscular disease that can cause muscle atrophy at a lower limb, without any support in the ICU

  2. Control group - BIOBANK-MALICUS

Inclusion criteria:

  • Elective surgery requiring an ICU stay (neurosurgery, vascular surgery, thoracic surgery)
  • Expected duration of ventilation shorter than 48 hours

Non inclusion criteria:

• Elective surgery with cardiopulmonary bypass

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High-risk patient for malnutrition acquired in ICU

Controls patients: Elective surgery

Arm Description

Patients admitted in ICU and treated with mechanical ventilation with expected duration of 48 hours or more

Controls patients: Elective surgery (neurosurgery, thoracic surgery, vascular surgery) - Patients admitted in a post-operative care unit of the university hospital of Nantes after elective surgery with expected duration ICU length of stay < 48 hours

Outcomes

Primary Outcome Measures

Sensitivity of ultrasound measurement of the quadriceps muscle anteroposterior diameter for the diagnosis of malnutrition in patients requiring mechanical ventilatory support in ICU
Anteroposterior diameter of the quadriceps muscle (mid-thigh distance between the anterior superior iliac spine and the upper pole of the patella) will be compared with biochemical method (prealbumin levels). Patients will be classified as true positive, true negative, false positive or false negative relative to the gold standard (biochemical method). The sensitivity and the specificity of ultrasound method to detect malnutrition will be calculated with their 95% confidence interval.

Secondary Outcome Measures

Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and Interleukin 6 level
Biospecimen collection (serum) Blood serum for biological specimen of pro-inflammatory cytokines (IL-1, IL-6 and TNF-α), inflammatory proteins (C-Reactive Protein) and total oxidative stress (PATROL® test)
3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline
NUTRIC-Score

Full Information

First Posted
September 28, 2015
Last Updated
September 27, 2022
Sponsor
Nantes University Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02564159
Brief Title
Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit
Acronym
MALICUS
Official Title
Ultrasound Measurement of the Quadriceps Muscle Diameter for the Detection and the Follow-up of Malnutrition in Patients Receiving Mechanical Ventilation in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Study Start Date
October 30, 2015 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Malnutrition is a major risk factor for morbidity and mortality of patients managed in intensive care unit. Early recognition and treatment of adult malnutrition are recommended in acute care settings especially for patients requiring mechanical ventilation. Biochemical indicators like serum concentrations of albumin and prealbumin (transthyretin) have a tradition of being used as markers of nutritional status but remains influenced by nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound method has gained interest for screening and follow-up of muscle weakness at the bedside in critically ill patients. In this light, the MALICUS project aims to investigate the validity of ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit. Skeletal muscle is central to cytokine regulation and it contributes 85% of total body glucose clearance. Some research findings suggest that muscle wasting is a smoldering inflammatory state partially driven by cytokines and oxidative stress but these conclusions need to be investigated in context of critically ill patients and perioperative settings. The investigators search to determine impact of inflammatory biomarkers (IL-1, IL-6 and TNF-α) and oxidative stress (evaluated by quantifying the global anti-oxidative defenses in patient with an original method (Patrol® test) based on the use of excited molecular oxygen (singlet oxygen) as a source of ROS on erosion of lean body mass measure with quadriceps muscle ultrasound. Consequently, in an ancillary study of the MALICUS project, the investigators wish to investigate interaction between acute inflammation and muscle wasting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Critical Illness
Keywords
malnutrition, muscle ultrasound, intensive care unit, mechanical ventilation, albumin, prealbumin, nutrition

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-risk patient for malnutrition acquired in ICU
Arm Type
Experimental
Arm Description
Patients admitted in ICU and treated with mechanical ventilation with expected duration of 48 hours or more
Arm Title
Controls patients: Elective surgery
Arm Type
Other
Arm Description
Controls patients: Elective surgery (neurosurgery, thoracic surgery, vascular surgery) - Patients admitted in a post-operative care unit of the university hospital of Nantes after elective surgery with expected duration ICU length of stay < 48 hours
Intervention Type
Other
Intervention Name(s)
Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels
Intervention Description
Evaluation of quadriceps diameter on the anterior aspect of the thigh using the mid-distance between the anterior superior iliac spine and the upper pole of the patella ; Biospecimen collection: Blood samples (prealbumin levels, C-reactive protein, Interleukin-1, Interleukin-6, TNF-alpha and PATROL test™)collection of albumin and prealbumin levels
Primary Outcome Measure Information:
Title
Sensitivity of ultrasound measurement of the quadriceps muscle anteroposterior diameter for the diagnosis of malnutrition in patients requiring mechanical ventilatory support in ICU
Description
Anteroposterior diameter of the quadriceps muscle (mid-thigh distance between the anterior superior iliac spine and the upper pole of the patella) will be compared with biochemical method (prealbumin levels). Patients will be classified as true positive, true negative, false positive or false negative relative to the gold standard (biochemical method). The sensitivity and the specificity of ultrasound method to detect malnutrition will be calculated with their 95% confidence interval.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and Interleukin 6 level
Description
Biospecimen collection (serum) Blood serum for biological specimen of pro-inflammatory cytokines (IL-1, IL-6 and TNF-α), inflammatory proteins (C-Reactive Protein) and total oxidative stress (PATROL® test)
Time Frame
8 days
Title
3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline
Description
NUTRIC-Score
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Study Population Subjects will be enrolled from 2 venues: Adults ICU patients (> 18 years) requiring period of mechanical ventilation. Subjects affiliated with an appropriate social security system Adults patients admit requiring ICU length of stay < 48h after eligible surgery MALICUS Study Inclusion Criteria: - Patient requiring invasive mechanical ventilation - Expected duration of ventilation longer than 48 hours - Age > 18 years Subjects affiliated with an appropriate social security system Non inclusion Criteria: - Invasive mechanical ventilation started for more than 48 hours - Patient severely malnourished at baseline (at least one of the following criteria) Prealbuminemia < 0,11 g/L BMI ≤ 18,5 (or ≤ 22 beyond 70 years) Unintentional weight loss > 5% in the previous month or > 10% in the last 6 months - Glomerular nephropathy history/nephrotic syndrome, chronic renal failure (MDRD < 30 ml/min), liver cirrhosis or exudative gastro-enteropathy - Glucocorticoid (> 10 mg / day of prednisone equivalent ) long-term therapy ( > 1 month) - Impossible ultrasound measure of anterolateral diameter for the two quadriceps muscles - Neuromuscular disease that can cause muscle atrophy at a lower limb, without any support in the ICU Control group - BIOBANK-MALICUS Inclusion criteria: Elective surgery requiring an ICU stay (neurosurgery, vascular surgery, thoracic surgery) Expected duration of ventilation shorter than 48 hours Non inclusion criteria: • Elective surgery with cardiopulmonary bypass
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand ROZEC, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit

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